Agricultural Biotechnology: Background and Recent Issues

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Congressional Research Service Reports Congress of the United States

2010

Agricultural Biotechnology: Background and Recent Issues

Tadlock Cowan

Congressional Research Service

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Agricultural Biotechnology: Background and

Recent Issues

Tadlock Cowan

Analyst in Natural Resources and Rural Development

September 2, 2010

Congressional Research Service 7-5700 www.crs.gov RL32809

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Summary

U.S. soybean, cotton, and corn farmers have rapidly adopted genetically engineered (GE) varieties of these crops since their commercialization in the mid-1990s. Over the last decade, GE varieties in the United States have increased from 3.6 million acres to 143 million acres.

Worldwide, 25 countries planted GE crops on approximately 309 million acres in 2008. GE varieties now dominate soybean, cotton, and corn production in the United States, and they continue to expand rapidly in other countries. As adoption has spread, policy debates have continued over the costs and benefits of GE products.

Ongoing concerns include the impacts of GE crops on the environment and food safety, and whether GE foods should be specially labeled. Underlying these issues is the question of whether U.S. regulation and oversight of biotechnology—with responsibilities spread primarily among the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA)—are adequate, particularly as newer applications, for example, biopharmaceuticals (drugs manufactured with the use of GE crops or animals) or stacked GE traits in single organisms, emerge that did not exist when the current regulatory regime was established.

Regulatory noncompliance incidents most pointedly raise concerns about the adequacy of

existing U.S. regulatory structures. About 16 major events have occurred since 1995, according to USDA’s Animal and Plant Health Inspection Service (APHIS). Another recurring concern has been the adequacy of APHIS’s environmental assessments (EAs) for deregulating GE plants. In 2006, a U.S. district court held that USDA’s EA for a variety of GE alfalfa was inadequate for issuing a finding of no significant impact (FONSI); the court vacated APHIS’s decision to deregulate GE alfalfa and ordered APHIS to complete an environmental impact statement (EIS). The federal court subsequently enjoined further planting until the EIS was completed. In July 2010, the Supreme Court overturned the federal court’s decision to enjoin planting. The final EIS is expected by the end of the year, but APHIS has not indicated an intent to allow planting under a “partial deregulation” in the interim. A similar case involves APHIS’s decision in 2005 to

deregulate GE sugar beets on the basis of its EA. That decision was also challenged, and the federal court vacated the deregulation of the GE sugar beets and ordered APHIS to complete an EIS. In July 2010, the federal court declined to enjoin GE sugar beet planting, but in vacating APHIS’s decision to deregulate the GE beets, the court has effectively halted planting, except under regulated conditions. APHIS is currently evaluating a request to partially deregulate GE sugar beets for 2011.

In October 2008, APHIS announced the first revision of its biotechnology regulations since their promulgation in 1987. Proposed changes include a multi-tiered permitting system, new risk categorizations for assessing environmental releases of GE organisms, regulation of GE plants that produce pharmaceutical and industrial compounds, and new standards for low-level presence of regulated GE products. A final rule on the proposed changes has not yet been published. Other recent issuances include FDA’s January 2009 final guidance on regulation of GE animals and products. APHIS is now seeking public comment and data concerning ongoing and future research on GE animals. In a ruling in January 2008, APHIS published its final guidance on the safety of meat and milk from cloned animals.

Legislative activity in the 111th Congress was modest. Two bills (H.R. 5578 and H.R. 5579) were introduced by Representative Kucinich, who had introduced similar bills in previous years.

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Figures

Figure 1. Global Acreage Planted to GE Crops, 1996-2009... 2

Figure 2. Adoption of Genetically Engineered Crops in the United States, 1996-2009... 3

Tables

Table 1. U.S. Acreage in Major GE Crops, 1996 and 2008-2009... 3

Table 2. World’s Largest Seed Companies ... 24

Table 3. Monsanto’s Global Share of Genetically Engineered Crops ... 25

Table 4. Monsanto’s Share of Global Vegetable Seed Markets ... 25

Contacts

Author Contact Information ... 35

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Adoption of Biotechnology in Agriculture

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Farmers have always modified plants and animals to improve growth rates and yields, create varieties resistant to pests and diseases, and infuse special nutritional or handling characteristics. Such modifications have been achieved by crossbreeding plants and animals with desirable traits, through hybridization, and other methods. Now, using recombinant DNA techniques, scientists also genetically modify plants and animals by selecting individual genes that carry desirable traits (e.g., resistance to a pest or disease) from one organism, and inserting them into another,

sometimes very different, organism, that can be raised for food, fiber, pharmaceutical, or industrial uses.

Karl Ereky, a Hungarian engineer, coined the term “biotechnology” in 1919 to refer to the science and the methods that permit products to be produced from raw materials with the aid of living organisms.2 According to the Convention of Biological Diversity, biotechnology is “any

technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use” (Article 2). According to the FAO’s statement on biotechnology, “interpreted in a narrow sense, ... [biotechnology] covers a range of different technologies such as gene manipulation and gene transfer, DNA typing and cloning of plants and animals.”3

Since genetically engineered (GE, sometimes called genetically modified organism or GMO) crop varieties first became commercially available in the mid-1990s, U.S. soybean, cotton, and corn farmers have rapidly adopted them in order to lower production costs and increase crop yields. Proponents point to the emergence of “second generation” GE commodities that could shift the focus of biotechnology from the “input” side (creating traits that benefit crop production, such as pest resistance) to the “output” side (creating traits that benefit consumers, such as lower-fat oils). These second generation products could offer enhanced nutritional and processing qualities and also industrial and pharmaceutical uses. Future products are expected to be livestock- as well as crop-based. Critics, meanwhile, complain that biotechnology companies generally have not yet delivered the consumer benefits they have been promising for years. Incidents of regulatory noncompliance have continued to spike concern about the adequacy of regulatory structures. In December 2008, a small amount of unapproved GE cotton was harvested along with commercially available GE cotton. The unapproved GE cotton variety produces a pesticide that is a plant-incorporated protectant (PIP). In August 2006, traces of an unapproved variety of GE rice were reported in commercial rice samples from parts of the southern United States (see “GE Rice,” below). These incidents have added to the ongoing interest in a number of public policy questions. What are the environmental and food safety impacts of GE crops and animals? What obstacles and opportunities are exporters of GE crops encountering in the global marketplace? Is the current U.S. regulatory framework, which is based primarily upon statutory authorities enacted before the rise of agricultural biotechnology, adequate for these new

technologies and products?

1

Among the sources for this report are various materials by USDA’s Economic Research Service (ERS) and Animal and Plant Health Inspection Service (APHIS), the Pew Initiative on Food and Biotechnology, various issues of Food

Chemical News, a weekly trade publication, and the Biotechnology Industry Organization (BIO).

2

OECD. Policy Brief, Modern Biotechnology and the OECD, June 1999. http://www.oecd.org/dataoecd/29/40/ 1890904.pdf.

3

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Current Applications

Crops

In 2008, GE crops were planted on an estimated 308.8 million acres worldwide, a year-over-year increase of 26.4 million acres (Figure 1). The total number of countries growing such crops reached 25 in 2008. Most of the acreage was highly concentrated among four crops—soybeans, corn, cotton, and canola—and six countries. The United States has approximately 50% of global acreage (154.4 million acres), and Argentina had 16.8% (51.9 million acres). Brazil (12.6%, 39.0 million acres), Canada (6.1%, 18.8 million acres), India (6.1%, 18.8 million acres), and China (3.0%, 9.4 million acres) have the largest shares of the remaining planted acres.4

Figure 1. Global Acreage Planted to GE Crops, 1996-2009

Source: International Service for the Acquisition of Agri-biotech Applications (ISAAA), Clive James, 2007 ISAAA Report on the Global Status of Biotech/GM Crops. Accessed July 2009 at http://www.isaaa.org/resources/ publications/briefs/37/executivesummary/default.html.

In the United States, over 60 GE plant varieties were approved by APHIS for commercial use through early 2005.5 By 2009, 70 plant varieties had been deregulated by APHIS. Ninety-one percent of all U.S. soybean, 88% of all upland cotton, and 85% of all corn acres were planted with GE seed varieties in 2009, according to USDA’s National Agricultural Statistics Service (Figure 2, Table 1). Virtually all current commercial applications benefit the production side of agriculture, with weed and insect control by far the most widespread uses of GE crops in the United States and abroad.

4

International Service for the Acquisition of Agri-biotech Applications (ISAAA), ISAAA Brief 39-2008, Executive

Summary: The First Thirteen Years, 1996 to 2008 Report on the Global Status of Biotech/GM Crops. Accessed January

2008 at http://www.isaaa.org/resources/publications/briefs/39/executivesummary/default.html

5

Sources: Information Systems for Biotechnology at Virginia Tech; also, USDA, ERS, The First Decade of

Genetically Engineered Crops in the United States, April 2006, which can be accessed at http://www.ers.usda.gov/

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Figure 2. Adoption of Genetically Engineered Crops in the United States, 1996-2009

Source: USDA Economic Research Service

Notes: Data for each crop includes more recently developed varieties engineered with both herbicide tolerance and pest resistance. These multiple trait plants are referred to as “stacked trait” varieties.

Table 1. U.S. Acreage in Major GE Crops, 1996 and 2008-2009 (acres in millions)

Soybeans Upland Cotton (UC) Corn

Acres % of all soy planted Acres % of all UC planted Acres % of all corn planted

1996 4.2 7 2.2 17 2.9 4

2008 68.6 92 7.7 86 69.9 80

2009 77.5 91 7.8 88 73.9 85

Source: USDA-NASS. Acreage Report, June 2009.

Herbicide-tolerant (HT) crops are engineered to tolerate herbicides that would otherwise kill them along with the targeted weeds. These include HT soybeans, HT upland cotton, and to a lesser extent, HT corn. Many of these are referred to as “Roundup Ready” because they are engineered to resist Monsanto’s glyphosate herbicide, marketed under the brand name

“Roundup.” More recently, Monsanto has announced various “stacked trait” varieties—varieties that combine resistance not only to glyphosate/Roundup but also to the herbicides dicamba and glufosinate.

Insect-resistant crops effectively have the pesticide inserted into the plants themselves to control insect pests for the life of the crop. These varieties are often referred to as having a

plant-incorporated protectant (PIP). Many of these crops have been genetically engineered with Bt (Bacillus thuringiensis, a soil bacterium), which produces a naturally occurring pesticide.6 These

6

Because Bt is a natural occurring pesticide, it can be used under certain conditions on organically produced plants. Its incorporation into GE commodities concerns some organic producers because of the risk of creating Bt tolerant pests (continued...)

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insect-resistant varieties are most prevalent in upland cotton to control tobacco budworm, bollworm, and pink bollworm; and in corn to control earworm and several types of corn borers. Monsanto is also developing “stacked trait” varieties of soybeans and sugar cane that are resistant to insects as well as glyphosate/Roundup.

Other crops approved for commercialization have included varieties of flax, papaya, potatoes, radicchio, rapeseed, rice, squash, sugar beets, tobacco, and tomatoes. However, these are either not commercialized or not widely planted. For example, the biotechnology firm Calgene’s FlavrSavr tomato, first marketed to consumers from 1995 to 1997, was withdrawn after Calgene determined that the varieties being grown were not of consistently high quality. GE potato varieties peaked several years ago at 2%-3% of the market; they were discontinued by the seed developer in 2001, mainly after several fast food and snack food companies declined to buy them. Varieties of GE wheat and rice, as well as flax and radicchio, have received regulatory approval but have not been commercially marketed (and/or research has been discontinued), presumably due largely to perceived producer or consumer unease with them.

In contrast to abandoning certain approved GE products, a variety of white GE corn has recently begun to be used in tortilla making after initial resistance by food processors. Herbicide resistant GE sugar beets were only planted in large acreage in the 2008 crop year. While commercially available since 2000, Western beet growers did not plant them because sugar-using food companies (e.g., Hershey, Mars) and beet sugar industry groups (e.g., American Crystal Sugar) balked at the idea of GE beets, thinking that consumers would be opposed. That opposition—real or potential—has apparently subsided to the point that processors have cleared their growers to plant the GE variety.7 Nonetheless, the Center for Food Safety filed suit in January 2008

challenging APHIS’s deregulation of GE sugar beets arguing that wind-pollinated GE sugar beets will inevitably cross-pollinate with related crops being grown in proximity, contaminating conventional sugar beets and organic chard and table beet crops.8

Nonetheless, USDA reported that between 1987 and early 2005, APHIS had approved more than 10,700 applications to conduct field tests of various GE crop varieties (out of 11,600 received from companies and other researchers), which the USDA characterized as “a useful indicator of R&D efforts on crop biotechnology.” Nearly 5,000 applications were approved for corn alone, followed by soybeans, potatoes, cotton, tomatoes, and wheat. More than 6,700 applications were for HT and insect resistant varieties; the others were to test product quality, virus or fungal resistance, or agronomic (e.g., drought resistance) properties.9 By October 2008, APHIS had approved more than 13,000 field trials of GE plants, most of which continued to be crop plants bearing genes conferring resistance to certain insects or tolerance to certain herbicides.

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thereby decreasing the utility of Bt to organic farming operations.

7

Some of the reduced public opposition to the GE beets may be based on the fact that sugar crystals do not contain any remnants of the GE modified protein and, thus, could pose no dietary risk.

8

The legal challenge seeking an injunction against was filed in the U.S. District Court for the Northern District of California and also includes the Sierra Club and the Organic Seed Alliance as plaintiffs. The court filing may be accessed at http://www.centerforfoodsafety.org/pubs/Final%20Complaint.pdf.

9_{ERS, The First Decade of Genetically Engineered Crops in the United States. April, 2006. http://www.ers.usda.gov/}

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Animal Products

Fewer animal-based GE products are commercially available, notably excepting dairy production. Chymosin, a biotechnology-produced enzyme, is used widely in cheese production. Bovine somatotropin (BST, also known as “bovine growth hormone”) is a naturally occurring protein that can be produced in greater quantities through genetic engineering. The GE version of BST (rBST) was first approved by the U.S. Food and Drug Administration (FDA) in 1993. Reports suggest that more than 30% of all U.S. dairy cows are administered BST to boost milk production (by an estimated 10%-15%).10 Several other emerging animal biotechnologies, while not yet

commercialized, are believed by researchers to hold great promise (see “Future GE Applications,” below).11 In February 2009, FDA approved the first product from a transgenic animal, an anti-clotting protein derived from the milk of transgenic goats.12 The animals are genetically engineered to produce a recombinant human antithrombin III protein in their milk.13 A

Netherlands-based biotechnology firm also announced plans to seek U.S. and European approval in 2009 for Rhucin, made from a human protein purified from the milk of genetically engineered rabbits. The protein, C1 esterase inhibitor, helps control inflammation.

U.S. Food Products Containing GE Crops

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An estimated 70% of all processed U.S. foods likely contain some GE material. That is largely because two such plants (corn and soybeans, where farmers have widely adopted GE varieties) are used in many different processed foods. U.S. biotechnology rules do not require segregation and labeling of GE crops and foods, as long as they are substantially equivalent to those produced by more conventional methods (see “Regulation and Oversight,” below).

Soy-based ingredients include oil, flour, lecithin, and protein extracts. Corn-based ingredients include corn meal and corn syrups, used in many processed products. Canola oil (mostly imported from Canada, where GE-canola is grown) and cottonseed oil are used in cooking oils, salad dressings, snack foods, and other supermarket items. No GE-produced animals are yet approved for human consumption, although cheeses may contain chymosin, and dairy products may have been produced from milk containing GE-BST.

As noted earlier, because most other government-approved GE crops are not being grown commercially, few other GE-derived foods are reaching consumers.

10_{Milk containing rBST may be falling out of favor in some places. Wal-Mart, the largest grocery retail outlet in the}

United States, has a private label milk (Great Value Milk) that will be rBST free. Kroger completed a phase-out of rBST milk in February 2008. Safeway switched to rBST free milk in its private line, although it continues to sell other rBST milk. Starbucks began using only rBST free milk in January 2008.

11

Also see CRS Report RL33334, Biotechnology in Animal Agriculture: Status and Current Issues, by Tadlock Cowan.

12

“FDA approves drug product from transgenic goats.” Food Chemical News, February 9, 2009.

13

In September 2008, APHIS announced a request for public comment and technical empirical data concerning ongoing and future research on genetically engineered animals.

14

Sources include Cornell University, Genetically Engineered Organisms Public Issues Education Project (GEO-PIE), at http://www.geo-pie.cornell.edu/crops/eating.html, accessed on February 3, 2009; USDA, APHIS, Petitions of Nonregulated Status Granted or Pending by APHIS, at http://www.aphis.usda.gov/brs/not_reg.html and Colorado State University, Transgenic Crops: An Introduction and Resource Guide. The latter report is available at

http://www.colostate.edu/programs/lifesciences/TransgenicCrops/index.html. The site is not regularly maintained but archived materials are available through 2004.

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Analysts say some farmers are wary of planting GE crop varieties because their customers may be worried about their safety, although as the case of sugar beets noted above suggests, public opposition to GE products in processed food may be declining. Biotechnology supporters contend that safety concerns are unfounded because scientific reviews have found approved GE crop varieties to be safe, and that foreign governments are simply using such concerns to maintain barriers to imports.

Future GE Applications

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“Input” Traits

For farmers, new insect-resistant and herbicide-tolerant GE varieties are under development or have been developed for other crops besides corn, cotton, and soybeans. These include wheat and rice (see below), alfalfa, peanuts, sunflowers, forestry products, sugarcane, apples, bananas, lettuce, strawberries, and eventually other fruits and vegetables. Other traits being developed through genetic engineering include drought and frost tolerance, enhanced photosynthesis, and more efficient use of nitrogen. Tomatoes that can be grown in salty soils, and recreational turf grasses that are herbicide tolerant, pest resistant, and/or more heat and drought tolerant, also are under development. In animal agriculture, pigs have been engineered for increased sow milk output to produce faster-growing piglets. Cloned cattle also have been developed to resist mastitis. APHIS approved field trials in June 2007 for a transgenic sunflower with a carp growth hormone inserted. The GE sunflower would be used in aquaculture feed for farm raised shrimp. Currently awaiting government approval for food use are GE salmon that require as little as half the usual time to grow to market size. Other such fish could follow later.16

“Output” Traits

For processors and consumers, research on a range of GE products is continuing: oilseeds low in saturated and transfats; tomatoes with anti-cancer agents; grains with optimal levels of amino acids; rice with elevated iron levels; and rice with beta-carotene, a precursor of Vitamin A (“golden” rice). Other future products could include “low-calorie” sugar beets; strawberries and corn with higher sugar content to improve flavor; colored cotton; improved cotton fiber; delayed-ripening melons, bananas, strawberries, raspberries, and other produce (delayed-delayed-ripening

tomatoes already are approved); and naturally decaffeinated coffee. Critics, however, point out that, although biotechnology advocates have been forecasting the adoption of various “output” traits for some time, few have actually reached the marketplace.

Other plants being developed could become “factories” for pharmaceutical compounds. The compounds would be extracted and purified for human and animal health uses (among concerns

15

Sources include “Review of Agricultural Biotechnology,” hearing before the Subcommittee on Conservation, Credit, Rural Development, and Research of the U.S. House Committee on Agriculture, June 23, 2004 (Serial No. 108-34); BIO; Colorado State University; and ERS, Economic Issues in Agricultural Biotechnology (AIB-762), February 2001 (table, p. 19), at http://www.ers.usda.gov/publications/aib762/; and The First Decade of Genetically Engineered Crops

in the United States.

16

So far one GE fish, the “Glofish,” has been marketed in the United States. It is an aquarium fish that is not approved for consumption. For more on genetically engineered fish, see CRS Report RL32974, Genetically Engineered Fish and

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are whether they could “contaminate” food crops; see “Plant-Based Pharmaceuticals from Biotechnology,” below). Some varieties of plants under development could also produce

“bioindustrials,” including plastics and polyurethane. Future transgenic livestock also might yield pharmaceuticals and/or human organ and tissue replacements. To date, none of these innovations have been commercialized, although some have begun field trials.

Regulation and Oversight

Coordinated Framework for Regulation of Biotechnology

The basic federal guidance for regulating biotechnology products is the Coordinated Framework for Regulation of Biotechnology (51 Fed. Reg. 23302), published in 1986 by the White House Office of Science and Technology Policy (OSTP). A key regulatory principle is that genetically engineered products should continue to be regulated according to their characteristics and unique features, not their production method—that is, whether or not they were created through

biotechnology. The framework provides a regulatory approach intended to ensure the safety of biotechnology research and products, using existing statutory authority and previous agency experience with traditional breeding techniques. The three lead agencies are USDA’s Animal and Plant Health Inspection Service (APHIS), the Food and Drug Administration (FDA) at the Department of Health and Human Services, and the Environmental Protection Agency (EPA).

Animal and Plant Health Inspection Service

APHIS regulates the importation, interstate movement, and field testing of GE plants and

organisms that are or might be plant pests under the Plant Protection Act (PPA; 7 U.S.C. §7701 et

seq.). APHIS regulates animal biologics (i.e., viruses, serums, toxins for animal vaccines) under

the Virus, Serum, and Toxins Act (21 U.S.C. 151 et seq.). Specifically, GE plants that are or might be plant pests are considered “regulated articles” under APHIS regulations (7 CFR 340-340.9). APHIS authorization must be obtained prior to import, interstate movement, or environmental release, including field testing.

More specifically, a “regulated” plant cannot be introduced into the environment, or even field tested, unless its developer obtains APHIS authorization through either the (1) permit process or (2) notification process. Permits impose restrictions on movement and planting to prevent escape of plant material that may pose a pest risk. Sponsors follow APHIS guidance on testing and movements to ensure that the plant will not damage agriculture, human health, or the

environment. Plant-based pharmaceuticals virtually always must be developed under the permit process. However, most other GE crops have been developed under the notification option, an expedited procedure that is less rigorous than permitting. Notification can be used in lieu of permitting when the plant species is not considered a noxious weed (or weed in the release area) and other APHIS standards are met.

Regardless of the process chosen, after testing is completed, a developer next seeks “non-regulated status” from APHIS, the typical route to full commercialization and no further formal oversight. The developer must provide APHIS with extensive information on plant biology and genetics, and potential environmental and plant pest impacts that may result from the

modification. APHIS conducts a formal environmental assessment (EA) and has public comment periods before deciding whether to approve the developer’s request for “non-regulated status.”

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Food and Drug Administration (FDA)

FDA regulates food, animal feed additives, and human and animal drugs, including those from biotechnology, primarily to ensure that they pose no human health risks, mainly under the Federal Food, Drug and Cosmetic Act (FFDCA; 21 U.S.C. §301 et seq.) and the Public Health Service Act (42 U.S.C. §201 et seq.). Under the FFDCA, all food and feed manufacturers must ensure that the domestic and imported products they market are safe and properly labeled. All domestic and imported foods and feeds, whether or not they are derived from GE crops, must meet the same standards. Any food additive, including any introduced through biotechnology, cannot be marketed before it receives FDA approval. However, additives that have been determined to be “generally recognized as safe” (GRAS) do not need such preapproval.

To help sponsors of foods and feeds derived from GE crops comply, FDA encourages them to participate in its voluntary consultation process. All GE-derived products now on the U.S. market have undergone this process. With one exception, none of these foods and feeds were considered to contain a food additive, so they did not require approval prior to marketing. However, a May 1992 FDA policy statement noted that GE foods must undergo a special review under certain conditions, such as if the gene transfer produces unexpected genetic effects, changes nutrients or toxicant levels from the food’s traditional variety, might contain an allergen from another crop, or would be used to host an industrial or pharmaceutical substance, for example.17

In June 2006, FDA published new guidance under which developers of new plant varieties intended for food use—including those that are bioengineered—can provide FDA with any information about new proteins they are using in the early stages of crop development. This voluntary consultation is to occur prior to the stage of development where the new proteins might “inadvertently” enter the food supply. FDA believes that any potential risk from the low-level presence of such material in the food supply would be limited to the remote possibility of it containing or consisting of a new protein that might be an allergen or toxin.18

On January 15, 2009, the U.S. Food and Drug Administration (FDA) released final guidance on how it is to regulate GE animals and products. FDA is to do so under its existing statutory authority and regulations. Generally, GE-derived foods, for example, are to be regulated like non-GE foods; if their composition does not differ from their conventional counterparts, they will not have to be labeled. Nonetheless, developers of GE animals and of GE-derived products must gain FDA pre-market approval.

Although animal biotechnology involves many techniques other than cloning, this latter

technology has attracted widespread attention. A final risk assessment and industry guidance on the safety of meat and milk from cloned cattle, pigs, and goats and their offspring were released January 15, 2008, by FDA. The documents generally echoed FDA’s December 28, 2006, draft risk assessment, which found that such products are as safe to eat as those of conventionally bred animals. The FDA also concluded that cloning poses the same risks to animal health as those found in animals created through other assisted reproductive technologies—although the frequency of such problems is higher in cloning. (Scientists stress that cloning is an assisted

17_{See the FDA biotechnology website at http://www.cfsan.fda.gov/~lrd/biocon.html#policy.} 18

FDA’s Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use can be accessed at http://www.cfsan.fda.gov/~dms/bioprgu2.html. The guidance was issued in draft form in November 2004 and had earlier been proposed by OSTP in 2002.

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reproduction technique that does not involve any transfer or alteration of genes through GE.) The agency said it was no longer asking industry to refrain voluntarily from marketing the products of cloned animals and their offspring, although the U.S. Department of Agriculture (USDA) did ask that it be continued for products from clones (but not from the offspring of clones).19

Environmental Protection Agency (EPA)

EPA must approve the use of all pesticides, including those genetically engineered into plants, which it terms “plant-incorporated protectants” (PIPs). EPA essentially determines a PIP’s environmental safety through its authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA; 7 U.S.C. §136 et seq.). Also, under the FFDCA, the EPA establishes tolerances (i.e., safe levels) for pesticides in foods. Pre-commercial regulation is through a system of notifications for small-scale field tests or experimental use permits for larger field tests. As for any pesticide, EPA requires the manufacturer of a PIP to obtain a registration through a regulatory process intended to ensure its safe use environmentally.

In practice, all three agencies have more detailed procedures than described here for monitoring and approving the development and commercialization of GE crops and foods, particularly if they are for new uses (e.g., pharmaceuticals). However, the fundamental guiding policy assumption since 1986 has been that the biotechnology process poses no unique or special risks; therefore it demands no new laws beyond those that already govern the health, safety, efficacy, and

environmental impacts of more traditional production methods.

Assessments of Current Policy

The biotechnology industry, prominent U.S. agricultural groups, and many scientific authorities continue to subscribe to the current coordinated framework described above. They cite various studies in asserting that there is no evidence that current GE crops have harmed the environment or human health.20

These reports generally conclude that current GE crops likely pose no greater risks than

conventional varieties, that each GE product should be assessed on a case-by-case basis, and that the current U.S. regulatory framework is adequate. However, the reports have also suggested a number of administrative or regulatory changes that might be adopted to improve oversight. Critics, including some consumer and environmental groups, have gone further, raising questions about whether the current laws themselves remain adequate to protect human health and the environment, particularly as emerging GE applications—such as plant-based pharmaceuticals and industrial compounds, and transgenic animals, including insects—increasingly challenge the agencies’ regulatory capabilities. They see gaps in the existing pre-market approval processes,

19

See CRS Report RL33334, Biotechnology in Animal Agriculture: Status and Current Issues, by Tadlock Cowan.

20

These studies include the Institute of Medicine/National Research Council 2004 report Safety of Genetically

Engineered Foods: Approaches to Assessing Unintended Health Effects; the National Academy of Sciences/National

Research Council (NAS/NRC) 2002 report Environmental Effects of Transgenic Plants: The Scope and Adequacy of

Regulation; the NAS/NRC 2000 report Genetically Modified Pest-Protected Plants: Science and Regulation; the

Council for Agricultural Science and Technology (CAST) 2001 report Evaluation of the U.S. Regulatory Process for

Crops Developed Through Biotechnology; and the CAST 2002 report Comparative Environmental Impacts of Biotechnology-derived and Traditional Soybean, Corn, and Cotton Crops.

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and in post-market oversight of GE crops, that they contend may expose humans and the environment to unwarranted risks. These critics have argued that new legislation is needed to clarify agency roles and strengthen their regulatory authority, particularly over future novel GE applications.

A number of agricultural organizations, while not necessarily clamoring for new laws, have expressed wariness about some new biotechnology products now awaiting approval. Among other concerns, they worry about consumer acceptance, potential difficulties exporting these varieties to countries demanding the segregation and labeling of GMOs (or outright prohibition of GMOs), and the potential for inadvertently mixing GE with non-GE crops. The 2006 discovery of an unapproved variety of GE rice in commercial U.S. rice supplies, and the 2008 discovery of an unapproved GE cotton variety harvested with an approved variety, are indicative of the problem. Another court case involving the deregulation of Monsanto’s GE alfalfa also raised important concerns about the adequacy of APHIS regulatory regime. In May 2007, U.S. District Court for the Northern District of California in San Francisco held that APHIS had failed to properly consider the environmental effects of the GE alfalfa in granting approval.21 A coalition of farmers, consumers, and environmentalists, led by the Center for Food Safety, filed suit in 2006 alleging that GE alfalfa could create “super weeds” resistant to herbicide, hurt production of organic dairy and beef products, and cause farmers to lose export business due to risks of contamination to natural and organic alfalfa. Perhaps more than some other GE varieties, the GE alfalfa case raised important issues about the limitations of coexistence between traditional and GE production methods. The issue of whether gene flow from GE alfalfa could permanently harm growers who did not want to adopt GE varieties case was particularly clear in this case.22

USDA Advisory Committee Report

In late August 2006, USDA released a long-awaited status report by its Advisory Committee on Biotechnology and 21st Century Agriculture (AC21). The report covered biotech adoption and regulation, and included a discussion of the many outstanding policy issues. The AC21 report observed, for example, that “U.S. regulations are evolving slowly and many governing statutes were written before modern agricultural biotechnology was developed. That system may not be optimal to meet the needs of producers and consumers.”23

Although all the AC21 members agreed on the importance of ensuring the food and feed safety of transgenic crops, they had differing views “about whether the current FDA regulatory system for transgenic crops was adequate to ensure safety and public acceptance.” Among other

observations, the AC21 cited the lack of a “clear, comprehensive federal regulatory system to assess the environmental and food safety of transgenic animals before they are commercialized.”

21

In January 2008, APHIS announced the preparation of an environmental impact statement on GE alfalfa. See Federal

Register, Vol. 73, No. 4, January 7, 2008: 1198-1200

22

For a discussion of the technical issues in growing GE alfalfa in proximity to non-GE alfalfa, see the following University of California-Davis study: http://alfalfa.ucdavis.edu/2007AlfalfaConference/2007/07-96.pdf.

23

USDA Advisory Committee on Biotechnology and 21st Century Agriculture. Opportunities and Challenges in

Agricultural Biotechnology: The Decade Ahead. July 13, 2006. The committee consists of biotech industry,

agricultural, consumer and scientific representatives. Accessed January 2009 at http://www.usda.gov/wps/portal/!ut/p/ _s.7_0_A/7_0_1OB?contentidonly=true&contentid=AC21Reports.xml.

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All sides of the debate, however, continue to agree that whatever policy course is pursued in the future, it should provide for a clear, predictable, trusted regulatory process.24

Views on the FDA Guidance

The recent FDA guidance on early food safety evaluations for new plant varieties (issued in June 2006; see page 8) is widely viewed as that agency’s current policy thinking on AP. The

Biotechnology Industry Organization (BIO) supported the FDA guidance, noting that it “provides safety assurance, while also recognizing the fact that ‘adventitious presence’ is a natural part of plant biology, seed production, and the distribution of commodity crops.” Several food industry officials also characterized the guidance as an important step toward a science-based policy regarding AP. However, critics such as the Center for Food Safety (CFS), a food safety and environmental advocacy organization, have complained that the guidance will more likely encourage “contamination” of the food supply by GE varieties rather than improve safety oversight. Moreover, the policy does not attempt to define or quantify an acceptable level, or levels, of AP.25

In 2006, CFS sued FDA for allegedly failing to adopt any pre-market safety requirements for GE foods, or to require labels identifying foods containing GE material. The lawsuit sought the establishment of a mandatory, pre-market review system for all such foods.26 The case was subsequently dropped by agreement with the parties.

APHIS Oversight

USDA’s APHIS has taken a number of actions over the past several years intended to improve regulatory oversight (like FDA, utilizing its current legislative authorities). These have included consolidation of its activities under a new Biotechnology Regulatory Services (BRS) office; development of a compliance and enforcement unit to ensure GE developers’ adherence to the rules, and the publication of more stringent permit conditions for GE-derived plants for

pharmaceuticals and industrials (see “Plant-Based Pharmaceuticals from Biotechnology,” below). In the January 23, 2004, Federal Register, the agency published a notice of its intent to prepare an environmental impact statement (EIS) evaluating these regulations, and requesting public

comment on a number of possible changes. These include whether to broaden APHIS’s regulatory scope to cover GE plants that may pose a noxious weed risk or may be used as biological control agents; whether to establish new categories for field testing that delineate requirements based upon relative levels of potential risk; and whether to change (i.e., strengthen) its environmental reviews and permit conditions for GE plants producing pharmaceuticals and industrials. APHIS also solicited comments on ways that it might ease its requirements for lower-risk products. The agency received over 3,000 comments on its proposal.

24

The various arguments are explored in more depth in an April 2004 Pew Initiative report, Issues in the Regulation of

Genetically Engineered Plants and Animals. See http://pewagbiotech.org/.

25

As reported in “FDA issues ‘adventitious presence guidance for biotech plants,” in Food Chemical News, June 26, 2006. See page 17 for additional discussion of the AP issue.

26_{A copy of the lawsuit and an accompanying press release can be viewed at the CFS website at}

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OIG Criticisms

In a December 2005 audit report, USDA’s Office of Inspector General (OIG) criticized APHIS’s biotech regulation. Noting the approval, at that point, of more than 10,600 applications for GE tests at more than 49,300 field sites, the OIG expressed concern that “the Department’s efforts to regulate those crops have not kept pace.” Various weaknesses in the approval and inspection process “increase the risk that regulated genetically engineered organisms will inadvertently persist in the environment before they are deemed safe to grow without regulation,” the report observed.27

More specifically, the OIG stated that APHIS lacked basic information about the field test sites that it has approved, including their precise locations; and about what becomes of the crops— including those tested for pharmaceutical or industrial uses—after testing ends. Where notifications (rather than permits) were used, APHIS did not review applicants’ containment protocols. Among other things, the OIG noted that APHIS site inspection requirements were vague and not always fulfilled by inspectors, and that the agency’s guidance for containing GE crops and seeds needed strengthening.

Responding to the audit report, APHIS stated that most of the OIG recommendations “reaffirm APHIS’ decision to create the new Biotechnology Regulatory Service (BRS) and devote greater resources toward regulating biotechnology. Most of the recommendations are in line with changes that BRS has already enforced, is currently undertaking, or plans to implement.”28

In January 2009, the OIG released another report concluding that the department did not have an import control policy to regulate GE animals and that its import policy for GE crops could become outdated as other countries increase the number of biotechnology products.29

APHIS Regulatory Changes

In July 2007, APHIS published a draft environmental impact statement (EIS) as part of the evaluation of its regulatory structure. In October 2008, APHIS proposed a revision of its

regulations regarding the importation, interstate movement, and environmental release of certain GE organisms.30 The public comment period initially was to end on November 24, 2008, but was extended to June 29, 2009. A subsequent issue-focused meeting on the proposed rule changes was held on April 29-30, 2009. The final rule has not yet been published. These proposed revisions are the first since the regulations were established in 1987. Under current regulations, a GE organism is a regulated article if it is a plant pest or there is reason to believe it might become a plant pest. In the notification of the proposed regulation revisions, APHIS stated that technological advances have led to the possibility of developing GE organisms that do not fit within the plant pest definition, but still might cause environmental or other physical harm by the definition of a plant pest under the Plant Protection Act. According to APHIS, the new regulations would subject a GE

27

USDA, OIG. Animal and Plant Health Inspection Service Controls Over Issuance of Genetically Engineered

Organism Release Permits, accessed January 2009 at http://www.usda.gov/oig/webdocs/50601-08-TE.pdf.

28

“BRS OIG Report Frequently Ask Questions,” which responds in more detail to the OIG criticisms. It can be viewed at http://www.aphis.usda.gov/brs/brs_oig.html.

29

USDA, Office of the Inspector General, Southwest Region, USDA Controls Over Importation of Transgenic Plants

and Animals, Report No. 50601-17-Te, December 2008.

30

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organism to oversight based upon known plant pest and noxious weed risks of the parent

organisms, or based upon the traits of the GE organism, or based upon the possibility of unknown risks as a plant pest or noxious weed when insufficient information is available.31 The proposed regulations also include regulating GE seedlings, tubers, cuttings, bulbs, spores, etc.

APHIS further proposes to reorganize the regulations for permit applications and evaluation procedures by discontinuing its notification procedure, while retaining the permitting procedure. The proposed regulations would also establish a new petition procedure for APHIS to approve a new conditional exemption from the permit requirements, which is currently done by amending regulations.

For environmental releases, APHIS proposes a permitting system based on two primary risk-related factors: (1) the ability of the unmodified recipient plant species to persist in the wild and (2) the potential of the GE trait to cause harm based on the plant pest and noxious weed

definitions. With respect to the persistence factor, APHIS proposes grouping plant species into four risk categories based on the risk of persistence of the plant or its progeny in the environment without human intervention. Four similar risk categories are also proposed for potential harm caused by the GE trait. Other proposed regulatory changes include remediation authorities for failure to comply with regulations and agency response to low-level presence (LLP) of regulated plant materials in commercial seeds or grain that may be used for food or feed.

Reactions to the proposed revisions were mixed, and were, in part, the reason APHIS extended the original comment period and held public meetings on some of the more controversial proposed changes (e.g., scope of the regulatory changes, incorporation of the Plant Protection Act’s noxious weed authority into APHIS’s regulatory authority, revision of the permit process, and environmental release of GE crops that produce pharmaceutical and industrial compounds). In their comments on the proposed rule changes, biotechnology industry representatives and nongovernmental organizations expressed opposition to the expansion of APHIS authority to regulate GE organisms if they posed a risk as a plant pest or noxious weed. The industry representatives also took issue with the with the proposal to take a voluntary approach to GE regulation, arguing that it could have a significant impact on international trade.32 The Center for Food Safety (CFS) denounced the proposal, stating that “these proposed regulations may set in motion a process that would put many GE crops completely beyond the bounds of regulation.” CFS said that its biggest concern is that the proposed rules remove established criteria in

determining the very scope of regulation. In a similar response, the Union of Concerned Scientists denounced the proposed rules for failing to adequately protect the U.S. food supply from potential contamination from biopharm crops through cross-pollination or seed mixing between biopharm food crops and those food crops intended for consumption.33 In March 2009, more than 80 advocacy groups signed a letter urging Secretary of Agriculture Tom Vilsack to halt approving GE crops until the agency changes its regulatory approach to biotechnology.

31

Only a small fraction of weeds are considered to be noxious weeds. APHIS currently lists 98 aquatic, terrestrial, or parasitic plant taxa as noxious weeds.

32

“Industry, NGOs, strongly oppose proposed USDA biotech regulation.” Inside U.S. Trade, October 17, 2008. .

33_{Food Chemical News. “USDA Proposed Biotech Regulatory Overhaul to Mixed Reviews,” vol. 50, no. 34, October}

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The National Environmental Protection Act and

APHIS

After a GE variety is approved for release into the environment on a test basis, the owner of the GE seed generally petitions APHIS for “deregulated status” of the particular GE “event” that has been approved. This is the last step to full-scale commercialization of the GE plant. Once the GE plant is deregulated, it is no longer subject to APHIS regulation under 7 C.F.R. Part 340. A significant step in the deregulation process involves an assessment of the plant’s environmental impact. The National Environmental Policy Act (NEPA) requires federal agencies to prepare a detailed Environmental Impact Statement (EIS) for all “major Federal actions significantly affecting the quality of the human environment.” The regulations governing the finding of a significant effect are promulgated by the Council on Environmental Quality (CEQ). When an EIS is not categorically required, an agency may determine, from the data already at hand, that the environmental impacts are not significant enough to warrant an EIS. This judgment permits the agency initially to prepare an Environmental Assessment (EA) rather than the lengthier and more detailed EIS. An EA is a public document that briefly provides the basis for determining whether to move forward with an EIS or to make a finding of no significant impact (FONSI).

Several cases over the past five years have raised issues about the adequacy of APHIS’s

regulatory structure in moving to deregulate a GE plant. APHIS on several occasions has issued a FONSI on the basis of an EA and deregulated a GE plant, only to have that decision decisively challenged in court.

GE Alfalfa

A U.S. District Court held in February 2007 that APHIS failed to properly consider the

environmental effects of Monsanto’s GE alfalfa. The court vacated APHIS’s June 2005 decision deregulating GE alfalfa on the basis of an EA. In March 2007, the District Court of the Northern District of California issued a preliminary injunction, and in May 2007 the court issued a permanent injunction against planting or selling Monsanto’s line of GE alfalfa until a final EIS was prepared. In June 2009, the Ninth Circuit Court of Appeals affirmed the illegality of APHIS’s approval of deregulated status for Monsanto’s GE alfalfa.

Not only did the GE alfalfa have environmental implications for domestic producers, the suit, brought by a coalition of farmers and the Center for Food Safety, also cited the concerns of farmers who sell to export markets.34 Japan and South Korea, America’s most important alfalfa customers, have warned that they will discontinue imports of U.S. alfalfa if a GE variety is grown in this country. U.S. alfalfa exports total nearly $480 million per year, with about 75% going to Japan. The court disagreed with USDA’s assertion that exports to Japan would not be harmed by the deregulation of GE alfalfa.

On January 12, 2010, APHIS announced that the draft environmental impact statement concerning Monsanto and Forage Genetics International lines of GE alfalfa was available for

34_{Alfalfa is an open-pollinated plant. Non-GE alfalfa would be at risk of being pollinated through windborne pollen}

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public comment.35 A series of public meetings in several cities was also held on February 3, 4, and 9, 2010. After a three-week extension for comments, the comment period ended March 3, 2010. The final EIS, which will address the nearly 135,000 comments received, is expected to be published before the end of the year. APHIS has stated that the EIS will be completed in time for spring 2011 planting.

The court’s decision to enjoin planting GE alfalfa until the final EIS was published was appealed to the Supreme Court.36 The Court agreed to hear that case on January 15, 2010, and on April 27, 2010, the Court heard oral arguments. Monsanto’s appeal concerned whether the federal courts in the Ninth Circuit properly applied and interpreted the injunction standard in NEPA cases when they permanently enjoined planting until the EIS was complete. On June 21, 2010, in a 7-1 opinion written by Justice Alito, the Supreme Court reversed the injunction, saying that the Ninth Court had overreached itself procedurally in halting the plantings. As of late August 2010, APHIS has not announced any intention to re-authorize the restricted plantings. Were APHIS to do so, any planting of GE alfalfa would have to be done under a rule for “partial deregulation,” a modification of existing planting restrictions for regulated organisms, perhaps limiting planting to specific geographic areas under controlled procedures. Such a partial deregulation, however, could trigger the need for a new EA on the impact of partial deregulation.

GE Sugar Beets

In February 2005, APHIS issued a finding of no significant impact on the environment (FONSI) for the cultivation and agricultural use of a Monsanto-developed variety of glyphosate-tolerant sugar beet (Event H7-1).37 The ruling meant that GE beets were no longer a regulated article under 7 C.F.R. Part 340. The GE beets were first planted in the western United States in spring 2008. Similar to the response to APHIS’s FONSI regarding GE alfalfa, a case was filed in U.S. District Court for the Northern District of California by the Center for Food Safety and

Earthjustice in January 2008 representing a coalition of farmers and consumers.38 As with the alfalfa case, the plaintiffs claimed that APHIS had violated NEPA by not conducting an EIS before granting the GE beets unregulated status.

Sugar beet seed is grown primarily in Oregon’s Willamette Valley. The area is also an important seed growing area for crops closely related to sugar beet (e.g., chard and table beets). Sugar beets, like alfalfa, are wind pollinated. Eventually, GE beets would cross-pollinate with related crops. This would have significant economic impacts on organic producers of Swiss chard and table beets being grown in the same areas as the GE beets. In his September 2009 order requiring APHIS to prepare an EIS, the presiding judge determined that “the potential elimination of a farmer’s choice to grow genetically engineered crops, or a consumer’s choice to eat non-genetically engineered food, [is] an action that potentially eliminates or reduces the availability of a particular plant [and] has a significant effect on the human environment.” The court concluded that there was no support in the record for APHIS’s conclusion of no significant impact.

35

The draft EIS may be downloaded at APHIS’s website: http://www.aphis.usda.gov/biotechnology/downloads/alfalfa/ gealfalfa_deis.pdf.

36

Monsanto Co. v. Geerston Seed Farms, 130 S. Ct. 2743 (2010)

37

Monsanto Company and KWS SAAT AG Petition 03-323-01p for Determination of Nonregulated Status for Roundup-Ready Sugar Beet Event H7-1. USDA/APHIS Environmental Assessment and Finding of No Significant Impact, February 2005. Document available at http://www.aphis.usda.gov/brs/aphisdocs2/04_11001p_com.pdf.

38

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At a meeting in December 2009, the U.S. District Court for the Northern District of California set out a schedule and process for determining the remedies regarding the sugar beets. The process did not interfere with the planting of the beets in 2010. Oral arguments were heard on June 11, 2010. On August 13, 2010, the court revisited the issue of whether to issue an injunction, as had been done with GE alfalfa. Given that the Supreme Court had just ruled that the injunction for GE alfalfa was improper, the Ninth Court vacated APHIS’s deregulation decision without enjoining planting. While avoiding the “drastic remedy,” as the Supreme Court described the injunction of GE alfalfa, the practical effect of vacating APHIS’s GE sugar beet deregulation decision is that planting GE sugar beet is now effectively halted. Because nearly 95% of sugar beets planted in 2009/2010 are the GE variety, this raises questions about the availability of non-GE sugar beet seed for the 2011 planting season.

GE Ethanol Corn

In June 2009, APHIS filed a request for additional comments on a petition by Syngenta Seeds, Inc. to deregulate Alpha-Amylase Maize Event 3272.39 This GE variety of corn produces a microbial enzyme that facilitates ethanol production. APHIS has prepared a draft EA and plant pest risk assessment for review and comment. Most relevant in this request is that it is the first request to deregulate a GE plant variety that is intended solely for the use in the production of ethanol. The corn variety is not cultivated for human consumption or livestock feed, but rather is grown to improve the efficiency of converting corn starch to industrial ethanol. A concern is that there is inadequate scientific data or documentation to evaluate the possible impacts on food and feed should this variety be commingled with commodity corn supplies.40

GE Eucalyptus

APHIS granted a permit on May 12, 2010, to import a GE eucalyptus tree that is “cold-tolerant.” If commercialized, the hybrid Eucalyptus would be used for pulp and biofuel production.

Eucalyptus is a fast-growing tree that dominates tropical timber plantations. It is not native to the United States and has become invasive in some places. The permit was issued to a company called ArborGen, LLC. ArborGen is a joint initiative of International Paper, MeadWestvaco, and Rubicon. The permit authorizes planting and flowering on 28 sites across seven southern states (Alabama, Florida, Georgia, Louisiana, Mississippi, South Carolina, and Texas). The Center for Biological Diversity and other organizations have sued to set aside the approval on grounds that the potential environmental impacts have not been properly evaluated, nor has APHIS complied with congressional mandates enacted in the 2008 farm bill (P.L. 110-246) requiring more rigorous oversight of field testing for GE organisms.41

39

Federal Register, vol. 74, 106, June 4, 2009, http://www.aphis.usda.gov/brs/fedregister/BRS_20090604b.pdf.

40

In February 2008, APHIS, EPA, and FDA announced a coordinated response to a notification by Dow AgroSciences that the company had detected an unregistered GE pesticide product know as a plant-incorporated protectant (PIP) in three lines of its commercial hybrid seed lines. Concerns that plant-derived pharmaceutical and industrial products could enter the food and feed system are based on difficulties in ensuring that unapproved plants are not commingled with approved varieties.

41

Center for Biological Diversity, et. al v. Animal and Plant Health Inspection Service. Case 2:10-cv-14175-KMM. Document available at http://www.biologicaldiversity.org/programs/public_lands/forests/pdfs/Eucalyptus-Complaint-signed.pdf.

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Global Trade Concerns

The U.S. approach to biotechnology regulation contrasts with that of many major trading partners. For example, the European Union (EU), Japan, South Korea, New Zealand, and Australia either have or are establishing separate mandatory labeling requirements for products containing genetically modified ingredients; in many of these countries, consumer and official attitudes toward GE foods are more skeptical. Differing regulatory approaches have arisen at least partly because widely accepted international standards continue to evolve. Incidents, such as those discussed below, have disrupted U.S. exports and contributed to trade tensions.42

GE Rice

Although several GE varieties of rice have been approved for commercial use (“deregulated,” in regulatory parlance), none have been marketed, although they have been planted on test plots in the United States. In August 2006, the Secretary of Agriculture announced that “trace amounts” of an unapproved variety of GE rice had been found in samples of the 2005 crop of U.S. long grain rice. The Secretary and other USDA officials sought to reassure the rice trade and consumers that the findings posed no human health, food safety, or environmental concerns.

Owner Bayer CropScience had not asked APHIS to deregulate this particular line, called LLRICE601, which had been field tested between 1998 and 2001. Two other Bayer GE rice varieties, known as LLRICE62 and LLRICE06, had received commercial approval but have not been commercialized, USDA stated. Also, “[t]he protein in LLRICE601 is approved for use in other products” and “has been repeatedly and thoroughly scientifically reviewed and used safely in food and feed, cultivation, import and breeding in the United States, as well as nearly a dozen other countries around the world.”43

Nonetheless, the discovery unsettled rice markets and rekindled longtime criticisms of U.S. biotechnology regulatory policies. The U.S. rice crop is valued at nearly $2 billion annually. Exports represent approximately one-half or more of U.S. rice production annually on a volume basis, of which about 80% is long grain (the type in which GE material was detected), according to USDA statistics. Although the United States produces only about 1.5%-2% of the world rice crop, it was the fourth-leading exporter (behind Thailand, Vietnam, and India), with more than 13% of world market share in 2005.

Of the 4.4 million metric tons (MMT) exported in 2005, Mexico was by far the leading buyer, at 753,000 MT. Japan was the second-leading market at nearly 424,000 MT. Various Central

42

See also CRS Report RL31970, U.S. Agricultural Biotechnology in Global Markets: An Introduction, by Geoffrey S. Becker and Charles E. Hanrahan. This report does not discuss the trade challenges encountered by the biotechnology companies themselves. Among other problems, besides foreign resistance to agricultural biotechnology in general, these companies also face often divergent laws on international property rights (IPR), where their patent or plant breeding rights in one country may be nonexistent in another. In the developing world in particular, the policy challenge is to find a balance between companies’ IPR and the ability to use the new technologies. For details, see International Food Policy Research Institute, Biotechnology and Genetic Resource Policies, Briefs 1-6, January 2003; and CRS Report RL31568, Plants, Patents, and Seed Innovation in the Agricultural Industry, by John R. Thomas.

43

“Statement by Agriculture Secretary Mike Johanns Regarding Genetically Engineered Rice,” August 18, 2006. LL stands for “Liberty Link,” a trademark name for the herbicide glyphosinate. LL crops are engineered to tolerate the herbicide, making for more effective weed control.

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American and Caribbean countries took a total of 1.4 MMT; Iraq, 310,000 MT; and European Union (EU) countries, a total of 306,000 MT, USDA data show. Much of the long grain crop is produced in southern U.S. states, which generally ship from Gulf ports to Latin America, the Caribbean, and Europe, for example. California grows mainly medium and short grain rice varieties, which are marketed in Asia, including Japan.

Following USDA’s notification that U.S. rice supplies had traces of GE material, September 2006 closing rice futures dropped from $9.70 per cwt. (100 pounds) on August 18, closing at $8.99 per cwt. on August 25, 2005. (One year ago, the closing price was less than $7.00 per cwt.) The European Union (EU), which bought 279,300 MT of U.S. long grain rice in 2005, reacted by adopting a measure requiring all such shipments to be tested and certified as free of LLRICE601. Japan has indicated that it was suspending shipments of U.S. long grain rice although, as noted, most U.S. rice exports there are short and medium grain.

According to a statement by the producer cooperative Riceland Foods, Inc., of Stuttgart, AR, the GE material was initially discovered by one of its export customers in January 2006. Riceland then sent a sample to a U.S. laboratory, which confirmed the Bayer GE trait, which is known to be present in (and approved for) corn, soybeans, canola, and cotton. Riceland said it collected samples from several storage locations in May 2006 and found positive results that were “geographically dispersed and random throughout the rice-growing area.” Bayer was notified in early June, and its tests confirmed the presence of the GE trait in the equivalent of 6 per 10,000 kernels (0.06%).44

In August 2006, USDA officials offered few additional details about the cause or extent of the problem. They indicated that they had not been informed by Bayer of the discovery until July 31, after which the Department began its own investigation, they stated. Among other actions, USDA said that APHIS was now moving to approve (i.e., deregulate) LLRICE601. Also, USDA’s Grain Inspection, Packers, and Stockyards Administration (GIPSA) has verified the use of two

standardized tests that can test for the GE protein in rice shipments.

Consumer and environmental advocacy groups were harshly critical of APHIS and USDA, noting that officials waited three weeks to make the discovery public—and still did not know where the samples were grown or how they entered the food supply. One group, the Center for Food Safety, subsequently called for a moratorium on all new field testing permits until oversight can be improved.45 In August 2006, rice farmers in Arkansas, Missouri, Mississippi, Louisiana, Texas, and California filed a class action lawsuit against Bayer CropScience, accusing the company of negligence in allowing unapproved genetically engineered rice to find its way into the

commercial supply chain. By November 2006, APHIS declared the rice variety LLRICE601 safe for human consumption and deregulated the variety. USDA essentially declared that the new variety was similar to two Bayer varieties that had already been approved.

44

Statement of Bill J. Reed, Riceland Foods’ vice president for public affairs, August 18, 2006, as quoted by the website AgWeb.com.

45_{Center for Food Safety, “Unapproved, Genetically Engineered Rice Found in Food Supply,” August 18, 2006, press}

Agricultural Biotechnology: Background and Recent Issues

Agricultural Biotechnology: Background and Recent Issues

Agricultural Biotechnology: Background and Recent Issues

Agricultural Biotechnology: Background and

Recent Issues

Tadlock Cowan

Analyst in Natural Resources and Rural Development

September 2, 2010

Summary

Contents

Figures

Tables

Contacts

Adoption of Biotechnology in Agriculture

Current Applications

Crops

Animal Products

U.S. Food Products Containing GE Crops

Future GE Applications

“Input” Traits

“Output” Traits

Regulation and Oversight

Coordinated Framework for Regulation of Biotechnology

Animal and Plant Health Inspection Service

Food and Drug Administration (FDA)

Environmental Protection Agency (EPA)

Assessments of Current Policy

USDA Advisory Committee Report

Views on the FDA Guidance

APHIS Oversight

OIG Criticisms

APHIS Regulatory Changes

The National Environmental Protection Act and

APHIS

GE Alfalfa

GE Sugar Beets

GE Ethanol Corn

GE Eucalyptus

Global Trade Concerns

GE Rice